Edinethics CEO Donald Bruce began extensive work on genetic modification and human gene therapies in the early 1990's with the Church of Scotland Society, Religion and Technology Project. In many respects the ethical questions posed by genome editing are very similar to those we explored in our ground breaking expert working group study Engineering Genesis and papers on gene therapy. But new technological developments throw new light on old issues and sometimes new issues
altogether. Here we introduce some of the questions ...

In humans. Whereas gene therapy to correct genetic 'defects' in adults or children is ethically widely accepted, even if the technique continues to prove extremely difficult to realise clinically, the same is not the case for 'germline modification', making permanent heritable genetic changes by altering the genes in embryos. This seen widely to be either unethical or too risky or both.

What of the Chinese claim to have produced two gene editied human babies? If the researcher has done what he says he has, by producing babies with novel changes to their genetic makeup, this represents a serious violation of a basic principle of ethics in medical research, which is that you do not produce human babies to be research subjects. These were apparently normal healthy embryos without a family disease history. There is no indication of any trials to attempt to
demonstrate the safety of the technique. The genetic change was, in effect, treating the babies to be born as experiments. This highlights a fundamental problem with any attempt to eradicate human diseases by editing the genetic code in an embryo - so-called germline gene therapy - that you can't demonstrate that it would be safe enough without experimenting on a lot of babies. Only in extreme cases might you consider it to be a medical exception, and this is certainly not one of them.

If the researcher has not done what he has claimed, it is a case like the Korean scientist Hwang who claimed to have produced cloned human embryos but was found to have false data. The issue is then how should the scientific and medical professions act to stop the rise in a kind of 'post-truth' science, where people claim sensational things in advance of proper scientific review.

Research on
early human embryos which would never be implanted
is a different ethical situation, but is still problematic. In the UK, such experiments could be legal, but what research should or should not be seen as justifying the ultimate destruction of embryos some of which would have been viable? This is especially the case with techniques that are so far new and relatively unproven, with important concerns of 'off-target' events, which may give misleading results.

It was of concern that, despite a call for widespread public debate on such issues by the UK's major medical research funding agencies, the Wellcome Trust and the Medical Research Council, that the HFEA quickly granted a license for the first application for such research, without any public debate having happened. The authorities should have waited before allowing such ground-breaking application to proceed before
its ethically acceptability has been
given a wider public scrutiny.

Many of the
first commercial applications of genome editing may be in food animals, which
are in some respects easier to modify with CRISPR than crops. These had not
hitherto been considered worthwhile for genetic modification by the animal livestock
breeding industry, but several applications have already been achieved at a
pilot scale. Forexample, the Roslin Institute have edited the genome of some pigs seeking to confer resistance to the serious pig disease porcine reproductive and respiratory syndrome (PRRS), which could have considerable benefits in animal welfare and in addition save a lot of money in production.

The researchers have also altered the genome of typical UK pigs to create a
mutation, found in some African
warthogs, which confers tolerance to the deadly pig disease African Swine Fever. This
could not be achieved by normal breeding, because the two species, while close,
do not interbreed. In this case, no ‘foreign’ DNA has been added to the pig, so
this does not constitute ‘transgenesis’, which was one of the main ethical
concerns about ‘conventional’ GM methods. The mutation might occasionally exist
unobserved within the UK pig population.

Such examples have prompted hopes in its proponents that genome editing might change both the
ethical and regulatory picture of genetically altered organisms. In practice
things are more complex. But if
other applications added significant numbers of DNA bases, these might be
considered similar to genetic modification. National regulatory bodies are
struggling whether to regulate the methods as ‘GM’ or with less stringent
rules.

When GM crops began commercial use in 1996,
the supporting rhetoric was its unprecedented precision and the unlimited
scope, compared with the uncertainties and restricted range of selective
breeding. When examined more closely, however, methods such as random ballistic
insertion did not seem like precision, and many of the more appealing
applications proved difficult like enhanced growth, nitrogen fixing, stress
tolerance and nutritional enhancements. Such second and third generation crops are
few. The vast majority of the world's use of GM crops remains in two now 20-year old traits, herbicide
tolerance and insect resistance. Public acceptability suffered greatly because
such applications brought no tangible benefits to consumers or retailers, were
perceived to carry long term environmental and health risks, and were imposedwithout choice.

By altering individual nucleotides in the DNA sequence, genomeediting seems to have the potential to deliver belatedly the claims for
precision and perhaps at last enable the wide range applications, and does not
normally involve transgenesis from other species. Would it now find acceptance
with the European public? Avoiding transgenesis would be effective for those
whose basic concern is about mixing genes across species or violating evolved
or God-given ‘barriers’. The notion that the edited sequence is capable of
occurring naturally would be attractive if one’s objection was to creating an ‘unnatural’
gene construct. On the other hand, it would not impress those for whom any genetic
alteration beyond selective breeding is unacceptable, a philosophical
objection, or people afraid of scientists ‘tampering with our food’, which has
elements of risk and revulsion.